The following data is part of a premarket notification filed by Standard Imaging, Inc. with the FDA for Doseview 3d.
| Device ID | K103193 |
| 510k Number | K103193 |
| Device Name: | DOSEVIEW 3D |
| Classification | Accelerator, Linear, Medical |
| Applicant | STANDARD IMAGING, INC. 3120 DEMING WAY Middleton, WI 53562 -1461 |
| Contact | Raymond T Riddle |
| Correspondent | Raymond T Riddle STANDARD IMAGING, INC. 3120 DEMING WAY Middleton, WI 53562 -1461 |
| Product Code | IYE |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-29 |
| Decision Date | 2010-12-27 |
| Summary: | summary |